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RecruitingPhase 3NCT07088380

Ketamine Augmentation of ECT in Treatment-Resistant Depression

The Additive Effect of Ketamine in Combination With ElectroConvulsive Stimulation (ECS) in Major Depressive Disorder (MDD): a Translational Study

Sponsor

Università Vita-Salute San Raffaele

Enrollment

30 participants

Start Date

Jul 10, 2025

Study Type

INTERVENTIONAL

Conditions

Major Depressive DisorderTreatment Resistant Depression

Summary

This is a randomized, double-blind, placebo-controlled phase 3 clinical trial evaluating the additive effect of intravenous ketamine in combination with electroconvulsive therapy (ECT) in patients with treatment-resistant major depressive disorder (MDD). The study aims to determine whether ketamine enhances the antidepressant efficacy of ECT and reduces associated cognitive side effects. Thirty hospitalized patients diagnosed with treatment-resistant MDD will be randomized to receive either ketamine or placebo (saline) during ECT sessions 2, 4, and 6. Primary outcome is the change in depressive symptoms, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) at 4 weeks.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding ketamine (an anesthetic drug with rapid antidepressant effects) to electroconvulsive therapy (ECT) improves outcomes for people with severe, treatment-resistant depression who have not responded to standard antidepressant medications. **You may be eligible if...** - You are 18–70 years old - You have been diagnosed with major depressive disorder (MDD) - Your depression is treatment-resistant (meaning at least 2 different antidepressants did not help) - You are scheduled to receive ECT - You can give informed consent **You may NOT be eligible if...** - You have a history of psychosis, bipolar disorder, or certain other psychiatric conditions - You have significant heart, liver, or kidney disease - You are pregnant or breastfeeding - You have contraindications to ketamine or anesthesia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKetamine Hydrochloride

Ketamine will be administered intravenously at a subanesthetic dose of 0.5 mg/kg after a bolus of Propofol, during ECT sessions 2, 4, and 6.

DRUGPlacebo

Placebo will be administered intravenously at a subanesthetic dose of 0.5 mg/kg after a bolus of Propofol, during ECT sessions 2, 4, and 6.

Locations(1)

IRCCS Ospedale San Raffaele Turro

Milan, Italy

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NCT07088380

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